TO: FROM: DATE: Advisory Update for Departments Using Participant Pools for Research University of Massachusetts Lowell, Office of Institutional Compliance, Institutional Review Board October 26, 2014 Several departments across UMass Lowell have developed participant pools to facilitate recruitment of research participants. These typically involve listing studies on a system such as SONA. The following information will also replace relevant sections in the current IRB Policies and Procedures Manual and will be updated on the www.uml.edu/Research/OIC website, under the IRB section. In the meantime, please review the advisory update. (Also updated in IRB Policies and Procedures, Revised October) Research Using Student “Subject Pools” Some UMass Lowell Departments use Subject Pools to recruit students for participation in human subject research. These pools are managed currently through the SONA system. All research posted on any UMass Lowell Subject Pool must have approval by the IRB prior to its posting. Use of online participant recruitment tools, such as SONA, also requires that information posted on the system be provided to the IRB in the application for approval. So that students can make an informed decision about whether to participate, all postings must include more than the title of the study. A brief description of the study purpose and method as well as an indicator of any potential risk must be added. Inclusion and exclusion criteria must also be outlined. Remember that individuals under age 18, even if they are college students, are considered minors and parental consent and assent documents may be required or in some cases, a full review IRB application may need to be submitted and approved before they may be included in any study. Age guidelines must be clear on any recruitment tools, including SONA listings. SONA listings must therefore include: Study title Very brief description of study purpose and method Brief indication of potential risk Inclusion criteria, including age 18 or older Exclusion criteria, including under age 18 The amount of participant time estimated to complete a study should be consistent across protocols by department for the types of credit, incentive, or compensation offered by the Department. Credit is earned for the participant’s effort not any specific research activity. If a one hour research credit is being awarded, the amount of effort should be one hour--or close to it. If 10 points of extra credit is being awarded for participation in research, the effort to obtain the extra credit should be consistent from one project to another. This requirement addresses the issue of coercion by over-payment or over-rewarding student participants in such pools. For example, participants may be unduly influenced to participate in Study A if it requires only 15 minutes when Study B requires 45 minutes to obtain the same credit. Departments may use the SONA system and student subject pools for either course credit or extra credit research experience, which may be obtained by participating in IRB-approved studies conducted in the department under the supervision of faculty. In addition, because research participation must be voluntary, an alternate method of fulfilling that academic requirement or extra credit opportunity must also be made available to students. Moreover, this alternate method must be an equivalent effort. If participating in a study for 30 minutes, for example, earns 2 points in extra credit, then the alternative cannot be writing a 5 page paper—it must be something that the student can do exerting no more effort than the research participation offered. Federal regulations indicate that research participants may not be penalized for a decision to withdraw from research at any time. Therefore, no department may penalize students for “no shows” when they have signed up for a study through the SONA system and then fail to attend the research session without cancelling the appointment in advance. It is not allowed to give the student a failing grade for the no-show or increasing the number of research participation credits to be required of the student. The regulations, however, do allow for departments to set a maximum number of times that students can turn to the studies offered to fulfill their academic requirement. In other words, students may be informed that they have a maximum of four opportunities to participate in research to get the credit, and that, should they decide not to participate in a specific study, failure to cancel their appointment in a timely fashion (e.g., 24 hours in advance, midnight the night before the study, etc.) will count as one of those four opportunities. Any unfulfilled research credits will then have to be completed by an alternative research experience once those four opportunities have been used. These procedures, for each Department that uses the SONA System, should be clearly outlined and provided to students in writing in advance. Brief studies may be combined. When projects are brief, investigators may elect to “double up” on some research sessions to keep the effort for any session consistent by the Department. This may especially be the case in student driven research projects. For example, if it really only takes 15 minutes to complete a survey for Study X, 20 minutes to complete the judgments required for Study Y, and 15 minutes to complete the memory tasks for study Z, they can be combined into one three-part experience that awards credit equivalent to one hour. Faculty may be required to submit one application that may include details on 2-3 completely unrelated studies. When combining studies, the following suggestions may be helpful in completing the IRB application. Study titles on the IRB application (also the titles that must be used for recruitment) could be something like "Two brief studies: Memory and Personality" where what follows the colon is a broad description about the topic of each study. Start off the IRB application with a statement something like, "This IRB application covers two projects that are sufficiently brief that students enrolled in the Psychology Participant Pool can complete both in a one hour session to earn a one-hour research credit. They are otherwise unrelated." Proceed with the application, answering each question for Study A. and Study B. That will allow you to cut and paste from the applications that student researchers have developed under your supervision. You can do the same with the Informed Consent, starting with a statement that, "You are being asked to participate in two brief studies that are presented in the same time slot in order to provide you with a one-hour research credit." Proceed for each item, labeling the information as Study A or Study B where appropriate and using one description for items where no distinction is required. Department Chairs should file a description of the pool and how it is intended to work with the UMass Lowell Director of the Office of Institutional Compliance (OIC). This will allow the IRB reviewers to have a clear understanding of the effort required by Department for the specific type of credit awarded by that Department. Department Chairs (or their designee) should consult with OIC before establishing student participant pools or making changes to them. The Informed Consent form must reflect the availability of alternatives to course credit. In a department where there is a research requirement in one course and in which others may offer extra credit for research participation (as in the Psychology Department), wording on the Informed Consent might be something like: “You will receive a one hour research participation course credit, which may be one way to fulfill a course requirement in General Psychology or one way to earn extra credit in another course depending on what course policy your instructor has set.” PLEASE NOTE: SONA awards credit in whole units; however the department may choose how much time and effort each unit represents. Typically one research credit or unit is equivalent to an hour, but it can also be equivalent to 30 minutes. This needs to be clearly indicated to students participating in the pool. The Psychology Department requires that all studies for which participants are recruited through the General Psychology Pool must have both IRB approval and at least one full-time faculty member from the psychology department listed as a PI. IRB approval is a requirement across the university. Other departments should determine which University PIs may recruit from their pool. Subject pools may also be used to recruit participants for research where monetary incentives are offered. Departments should decide on the best policy for managing recruitment for paying studies, i.e., whether such recruiting will be on the same platform as recruiting for participation credits in courses. Added to IRB Policy and Procedures, Sections: III. Investigator Guidelines, B. Research Using Student Subject Pool and V.IRB Administration and Operation Information, E. Application Review Information for IRB Members Added to Investigator Guidelines: D. Recruiting Participants from “Subject Pools”